Bezlotoxumab Injection
Bezlotoxumab Injection is an intravenous antibody medicine used alongside antibiotics to lower the chance that a Clostridioides difficile infection (CDI) comes back in people at high risk.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Bezlotoxumab (Zinplava) is a lab-made antibody, on the U.S. market since about 2016, that neutralizes toxin B from Clostridioides difficile bacteria. Given once by IV alongside antibiotics, it lowers the chance a C. diff infection comes back and is a specialist add-on for people at high risk of a repeat bout, not a treatment for the infection itself. Most people tolerate the infusion well, with nausea, fever or headache the most likely things to notice. The main warning is heart failure, seen more often in people who already have congestive heart failure, so for them it should be used only when the benefit outweighs the risk.
Clinical pearls
- Finish every dose of your C. diff antibiotic, because Zinplava only works alongside it and does nothing to clear the bacteria.
- Tell the nurse right away if your heart races, breathing gets hard or you feel dizzy during the hour-long infusion.
- Report new shortness of breath or swelling after the infusion promptly, especially if you have had heart failure.
- Your body breaks it down like a natural protein, so metabolic interactions with your other medicines are not expected.
Patient information guide A plain-language walkthrough of Bezlotoxumab Injection, written from its FDA label.
What Bezlotoxumab Injection is used for
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Bezlotoxumab Injection has one supported use:
- Zinplava is used to reduce recurrence of Clostridioides difficile infection (CDI) in adults and children 1 year and older who are receiving antibiotics for CDI and are at high risk of it returning.
- Zinplava is not used to treat CDI itself and is not an antibiotic.
How Bezlotoxumab Injection works
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Bezlotoxumab is a human monoclonal antibody. It binds to toxin B from C. difficile bacteria and neutralizes its effects. This is why it helps lower the risk of the infection returning, while antibiotics handle the infection itself.
Bezlotoxumab Injection dosage
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Zinplava is given by a healthcare professional as a single intravenous infusion over 60 minutes. It is given during antibiotic treatment for CDI, and the dose depends on body weight.
- It is diluted before use and given through a special filter.
- It is not given as a quick IV push.
- Repeat dosing has not been studied.
Because it is a one-time infusion, a missed-dose schedule does not apply. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Bezlotoxumab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and Pediatric Patients 1 year of age and older (CDI, administered during antibacterial drug treatment for CDI)
- A single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes
- Dilute prior to infusion to a final concentration ranging from 1 mg/mL to 10 mg/mL; administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Safety and efficacy of repeat administration have not been studied.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer ZINPLAVA during antibacterial drug treatment for CDI. ( 2.1 ) The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. ( 2.2 ) Dilute prior to intravenous infusion. Administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. See Full Prescribing Information for dilution and administration instructions. ( 2.3 ) 2.1 Important Administration Instructions Administer ZINPLAVA during antibacterial drug treatment for CDI. 2.2 Dosing Recommendations in Adults and Pediatric Patients 1 year of age and older The recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied. 2.3 Preparation and Administration Preparation of Diluted Solution ZINPLAVA must be diluted prior to intravenous infusion. Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution. Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains visible particles. Do not shake the vial. Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix diluted solution by gentle inversion. Do not shake. Discard vial(s) and all unused contents. Storage of Diluted Solution The product does not contain preservative. The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours. If refrigerated, allow the intravenous bag to come to room temperature prior to use. These time limits include storage of the infusion solution in the intravenous bag through the duration of infusion. Do not freeze the diluted solution.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Bezlotoxumab Injection side effects
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The most common side effects in adults were:
Common side effects
- Nausea
- Fever (pyrexia)
- Headache
- In children: fever and headache were the most common
- Infusion-related reactions such as fatigue, dizziness, shortness of breath or high blood pressure
When to get medical help
- Call your doctor or get medical help right away if you have new or worsening signs of heart failure, such as shortness of breath or swelling, especially if you have a history of congestive heart failure.
- Tell your care team right away if you feel unwell during the infusion, such as a racing or irregular heartbeat, trouble breathing, or dizziness.
- Report any worrying symptoms after your infusion to your healthcare provider.
In children, fever and headache were most common. About 10% of adults had infusion-related reactions, which were mostly mild or moderate and resolved within 24 hours. Seek help for symptoms of heart failure.
Bezlotoxumab Injection warnings and precautions
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- Heart failure: reported more often with Zinplava, mainly in people with a history of congestive heart failure.
- More deaths occurred in the Zinplava group among people with a history of congestive heart failure during the 12-week study.
- In these patients, it should be used only when the benefit outweighs the risk.
Bezlotoxumab Injection interactions
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No metabolic drug interactions are expected.
- The body breaks it down by catabolism, like other proteins, so it is not expected to clash with other medicines.
- It is used together with CDI antibiotics.
- Do not give other drugs through the same IV line at the same time.
Interactions listed in the FDA-approved label
From the Bezlotoxumab Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Metabolic drug-drug interactions (ZINPLAVA is eliminated by catabolism): No metabolic drug-drug interactions are expected since ZINPLAVA is eliminated by catabolism.
Read the label’s full interactions text
7 DRUG INTERACTIONS Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected [see Clinical Pharmacology (12.3) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Bezlotoxumab Injection
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- There are no contraindications listed.
- Tell your doctor if you have a history of congestive heart failure.
- Pregnancy: adequate studies have not been done.
- Breastfeeding: effects on milk or the infant are unknown, so weigh benefits and needs with your doctor.
- Children 1 year and older: safety and effectiveness are established. Under 1 year: not established.
- Older adults: no dose adjustment is needed.
Bezlotoxumab Injection overdose
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There is no clinical experience with overdose of Zinplava. If an overdose occurs, you should be closely monitored for side effects and given symptomatic treatment.
How your body processes Bezlotoxumab Injection
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Bezlotoxumab stays in the body for a long time. Its half-life is about 19 days. It is broken down by catabolism (the body's normal protein breakdown), not by liver enzymes.
Clearance rises with body weight, which is why dosing is weight-based. Gender, race, ethnicity and other health conditions did not meaningfully change exposure in adults.
How to store Bezlotoxumab Injection
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Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Bezlotoxumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Bezlotoxumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How will I get it?
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What side effects might I notice?
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I have heart failure. Is this safe for me?
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Will it interact with my other medicines?
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Can I get it if I'm pregnant or breastfeeding?
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Is Bezlotoxumab Injection available over the counter?
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When was Bezlotoxumab Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Bezlotoxumab Injection on HelloPharmacist
Bezlotoxumab Injection forms and strengths (how it comes)
Bezlotoxumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Bezlotoxumab Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Zinplava is used to reduce recurrence of CDI in adults and children 1 year and older receiving antibiotics for CDI who are at high risk of recurrence.
- Zinplava is not a treatment for CDI and is not an antibiotic.
- Zinplava is given as a single intravenous infusion over 60 minutes during antibiotic treatment for CDI.
- Zinplava must be diluted before infusion and given through a special in-line filter.
- Zinplava should not be given as an IV push or bolus, or through the same line as other drugs at the same time.
Bezlotoxumab Injection on the U.S. market: products, makers and brands
How Bezlotoxumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Bezlotoxumab Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2016. Brand names on the directory include Zinplava; the rest are generics.
Compare Bezlotoxumab Injection products
A representative set of FDA-listed product records for Bezlotoxumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 25 mg/mL | Intravenous | Merck Sharp & Dohme LLC | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Bezlotoxumab Injection NDCs →
Bezlotoxumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bezlotoxumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bezlotoxumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Bezlotoxumab Injection FDA approval history
How Bezlotoxumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Bezlotoxumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Bezlotoxumab recalls since July 2021.
✅No Bezlotoxumab recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1855048 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1855051In current FDA listingsClinical drug / strength (SCD) 40 ML bezlotoxumab 25 MG/MLRxCUI 1855052
Look up RxCUI 1855048 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Bezlotoxumab Injection supply and shortage status
Whether Bezlotoxumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Bezlotoxumab Injection brand names
Bezlotoxumab Injection is sold under one brand name in the FDA directory — Zinplava. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Bezlotoxumab Injection: manufacturers and labelers
One company lists Bezlotoxumab Injection products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Bezlotoxumab Injection drug class (RxNorm)
Bezlotoxumab Injection belongs to the Antibacterial monoclonal antibodies class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Bezlotoxumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →